Clinical Trial

Cognitive Outcomes After Dexmedetomidine Sedation in Cardiac Surgery Patients

Study acronym: CODEX
Recruiting Phase 4
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Summary
Anesthesia is a drug induced, reversible, comatose state that facilitates surgery and it is widely assumed that cognition returns to baseline after anesthetics have been eliminated. However, many patients have persistent memory impairment for weeks to months after surgery. Cardiac surgery appears to carry the highest risk of postoperative cognitive dysfunction (POCD). These cognitive deficits are associated with increased mortality, prolonged hospital stay and loss of independence. The investigators propose to investigate the role of Dexmedetomidine (DEX) in preventing long-term POCD after cardiac surgery and enhancing early postoperative recovery. It is anticipated that DEX will be the first effective preventative therapy for POCD, improve patient outcomes, and reduce length of stay and healthcare costs.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2020-02-27; most recent amendment 2025-11-27.
Trial Details
NCT Number NCT04289142
Lead Sponsor Sunnybrook Health Sciences Centre
Collaborators: London Health Sciences Centre, University Health Network, Toronto, McMaster University, Canadian Institutes of Health Research (CIHR), The Dana Foundation, Brain Canada, Alzheimer's Association, Hamilton Health Sciences Corporation, University of Saskatchewan, Fraser Health, Providence Health & Services
Conditions Delirium, Cognitive Dysfunction, Cognition Disorder, Neurocognitive Disorders, Mental Disorders, Confusion, Neurobehavioral Manifestations, Neurologic Manifestations +9 more
Enrollment 2,400 participants
Start Date 2019-12-01
Primary Completion 2028-07 (estimated)
Study Completion 2029-03 (estimated)
Updated on ClinicalTrials.gov 2025-12-01